Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma
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|ClinicalTrials.gov Identifier: NCT03223103|
Recruitment Status : Active, not recruiting
First Posted : July 19, 2017
Last Update Posted : June 1, 2018
The purpose of this study is to use precision medicine in the form of a vaccine, a mutation-derived tumor antigen vaccine (MTA-based vaccine) in combination with standard care treatment of glioblastoma (GBM) and Tumor Treating Fields (TTFields).
The study is designed to determine whether this treatment combination is well tolerated and safe.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Drug: Poly-ICLC Device: Tumor Treating Fields Biological: Peptides||Phase 1|
This is a single-arm, single institution phase 1a / 1b study to test the safety, tolerability, and immunogenicity of MTA-based personalized vaccine in patients with newly diagnosed GBM along with the use of continual TTFields. MTA-based personalized vaccine is prepared in the laboratory with several peptides based on each patient's own tumor sequence.
The vaccine is given after the radiation and chemotherapy portion of the treatment, in the maintenance phase of temozolomide in conjunction with the TTFields.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Tumor Treatment Fields and a Personalized Mutation-derived Tumor Vaccine in Patients With Newly Diagnosed Glioblastoma|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||May 22, 2019|
|Estimated Study Completion Date :||May 22, 2020|
Experimental: Mutation-derived tumor vaccine
MTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields
Poly-ICLC 100mcg per peptide per dose
Other Name: Hiltonol®
Device: Tumor Treating Fields
an FDA approved treatment for patients with recurrent GBM and newly diagnosed GBM
Other Name: Optune®
synthetic long peptides (SLP) as vaccine substrate
Other Name: Personalized peptides
- Dose-limiting toxicities (DLT) [ Time Frame: 42 weeks ]Feasibility administration of one vaccine; toxicity will be measured by severity of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale
- Toxicity grading using CTCAE scale [ Time Frame: 1 year ]Safety will be measured by number of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale
- The percent Progression Free Survival (PFS) [ Time Frame: 6 months ]
- Overall Survival (OS) Rate [ Time Frame: 1 year ]
- Overall Response Rate [ Time Frame: 2 years ]Overall response as measured by RANO Response Criteria: Complete response, Partial response, Stable Disease, and Progressive Disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223103
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Adilia Hormigo, MD, PhD||Icahn School of Medicine at Mount Sinai|